NCT01251835

Brief Summary

This study will assess how rifampin will affect the blood levels of sitaxsentan. Safety of sitaxsentan given alone and with rifampin will also be assessed.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 5, 2015

Status Verified

January 1, 2011

Enrollment Period

1 month

First QC Date

December 1, 2010

Last Update Submit

March 4, 2015

Conditions

Pulmonary Arterial Hypertension

Keywords

SitaxsentanRifampinDrug InteractionPharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.

    24 hours

  • Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.

    24 hours

Study Arms (2)

Sitaxsentan

ACTIVE COMPARATOR
Drug: Sitaxsentan alone

Sitaxsentan plus Rifampin

EXPERIMENTAL
Drug: SitaxsentanDrug: Rifampin

Interventions

Sitaxsentan aloneDRUG

Days 1-5: Sitaxsentan tablet, 100 mg, q24 h (once a day)

Sitaxsentan
SitaxsentanDRUG

Days 6-12: Sitaxsentan tablet, 100 mg, q24h (once a day)

Sitaxsentan plus Rifampin
RifampinDRUG

Days 6-12: Rifampin capsule, 600 mg, q24h (once a day)

Sitaxsentan plus Rifampin

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects and/or women of non-child bearing potential.
  • Subjects between the ages of 21 and 55 years, inclusive.
  • Signed informed consent.

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • Has hepatic dysfunction.
  • Has history of excessive alcohol and tobacco use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

sitaxsentanRifampin

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 2, 2010

Study Start

December 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 5, 2015

Record last verified: 2011-01